FDA Inspection
DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - HennriettaDJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta – FDA Inspection, Oct 12, 2023
Record Details
This FDA Inspection record concerns DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta, with an inspection on October 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 12, 2023
- Product Type
- Devices
View Company Profile
ID · 61c0a090-8f75-46fc-9230-28bb22860278
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220579
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.